This information is sent as follow up communication to the September 18, 2014 memo. On September 8, 2014 the Drug Enforcement Administration (DEA) released their final rule regarding the disposal of controlled substances which takes effect October 9, 2014. This rule governs the secure disposal of controlled substances by registrants and ultimate users. These regulations will implement the Secure and Responsible Drug Disposal Act of 2010 by expanding the options available to collect controlled substances from ultimate users for the purpose of disposal, including: take-back events, mail-back programs, and collection receptacle locations. Significant changes are made in this final rule which the DEA states are to help ensure that long term care centers have adequate disposal options. These changes are outlined below:

o (1301.51 Modification in registration) A hospital/clinic with an onsite pharmacy or retail pharmacy applying for a modification in registration to authorize such registrant to be a collector to maintain a collection receptacle at a long term care facility in accordance with 1317.80, shall also include the name and physical location of each long term care facility at which the hospital/clinic with an onsite pharmacy, or the retail pharmacy, intends to operate a collection receptacle.

Alleviates two security requirements proposed to apply to collection receptacles at long term care centers:

o DEA is permitting authorized hospitals/clinics and retail pharmacies to store inner liners that have been sealed upon removal from collection receptacle at long term care centers in securely locked, substantially constructed cabinet or securely locked room with controlled access for up to three business days until liners can be transferred for destruction.

o DEA relaxed the two employee integrity requirement for inner liner installation, removal, storage, and transfer at long term care centers. Collectors will retain the option to authorize two of their own employees to install, remove, store, and transfer inner liners; however, the DEA is permitting collectors the option to designate a supervisor-level employee of the long term care center (e.g., a charge nurse, supervisor, or similar employee) to install, remove, store, or transfer inner liners with only one employee of the collector.

o With this rule, the DEA allows all pharmaceutical controlled substances collected through take-back events, mail-back programs, and collection receptacles to be comingled with non-controlled substances, although such comingling is not required.

o Collection receptacle must be located in an area regularly monitored by long term care center personnel.

AHCA/NCAL would like to highlight three aspects of this rule that are important considerations from an operational perspective:

Definition of long term care facilities (LTCFs) - DEA’s definition of long term care facilities is broad and seems to include assisted living. LTCF is defined at 1300.01(b) and “means a nursing home, retirement care, mental care or other facility or institution which provides extended health care to resident patients.” (see page 53540 of Federal Register)

Definition of ultimate user - An ultimate user is defined by the CSA as a “person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or by a member of his household.”…Individuals lawfully entitled to dispose of an ultimate user decedent’s property are authorized to dispose of the ultimate user’s pharmaceutical controlled substances by utilizing any of the three disposal options. All of the collection methods are voluntary and no person is required to establish or operate a disposal program. The rule also does not require ultimate users to utilize any of these three methods for disposal of controlled substances…this rule does not prohibit ultimate users from using existing lawful methods. (see page 53521 of Federal Register)

Exposure to DEA inspection - The location of the collection receptacle is both a registered location and a controlled premise…LTCFs with authorized collection receptacles are “controlled premises” pursuant to 21 U.S.C. 880(a) and 21 CFR 1316.02(c); accordingly, the DEA may enter LTCFs and conduct administrative inspections in furtherance of, and in carrying out, the responsibilities charged to the DEA by the CSA pursuant to 21 U.S.C. 880 (b) and 21 CFR 1216.03. (see page 53541 of Federal Register)

Under the Secure and Responsible Drug Disposal Act of 2010, DEA already has the authority over disposal of controlled drugs (including in long term care centers), and they also have the authority to issue regulations governing disposal of drugs in long term care centers and to ensure compliance with those regulations. It is not clear how frequently DEA will visit centers if they do or do not have collection receptacles.

While the rule states it is voluntary to maintain collection receptacles at long term care centers, AHCA/NCAL recommends members seek advice of their legal counsel.